Spinal Cord Stimulation: Paresthesia-based SCS(PB-SCS), with stimulating frequencies between 30 to 80 Hz that confer a tingling sensation. Three different paresthesia-free SCS (PF-SCS) modes that use frequencies in the range of 400-10,000 Hz include Burst, High Frequency stimulation at 1.2 kHz and High Density stimulation at 400 Hz.
Study summary
Spinal cord stimulation (SCS) relies on stimulation of pain-relieving pathways in the spinal cord to treat chronic neuropathic pain. Traditional paresthesia-based SCS (PB-SCS) relies on providing analgesia through stimulation of spinal cord dorsal columns but it is often associated with attenuation of analgesic benefit and lack of acceptance of paresthesias. Recently introduced three different paresthesia-free (PF-SCS) modes of stimulation aim to overcome limitations of PB-SCS. Several questions regarding PB and PF SCS modes remain unanswered including the mechanisms of therapeutic benefit, criteria for selecting patients likely to benefit, and long-term outcomes. A concerted effort is required to understand and optimize utilization of SCS. This project has the twin goals of using neuroimaging techniques to understand mechanisms that underlies analgesic benefit from PB/PF-SCS modes and to identify criteria for selecting patients based on monitoring of pain and its related domains in patients undergoing SCS trials. Achieving these objectives will increase probability of analgesic benefit while minimizing adverse effects and knowledge gains from this study will be applicable to other therapies for chronic pain conditions.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Adults, 18 - 80 years of age, with refractory neuropathic pain (as per clinical features and DN4 score \> 3/10) in back and or lower limbs for more than 3 months following lumbar spine surgery
2. Severity of pain \> 3/10 on NRS and ODI score for disability \>40/100; and
3. Pain refractory to conventional medical management tried for at least 3 months.
Exclusion Criteria:
1. Age \< 18 or age ≥ 80 years;
2. Previous trial or implantation of SCS system;
3. Procedural contraindications to SCS including extensive thoracolumbar spine surgery, moderate-to-severe central canal stenosis, coagulopathy, local or systemic infection;
4. Pregnancy;
5. Opioid dose \> 200 mg OMED;
6. Psychiatric or psychological disorder likely to impact perception of pain;
7. Inability to comply with the study interventions or evaluate treatment outcomes;
8. Mechanical spine instability as per flexion/extension lumbar X-rays;
9. Ongoing litigation issues related to the pain; and
10. Concomitant peripheral neuropathy or myopathy or central neuropathic pain (e.g. post-stroke pain).
Primary outcome measure(s)
Changes in neuronal activity with the novel PF-SCS modes as detected by fMRI and MEG — 12 days after the initiation of the SCS trials )
Changes in neuronal activity with the novel PF-SCS modes as detected by fMRI and MEG — 6 months after the initiation of the SCS implants
To measure long-term outcomes of novel PF-SCS modes including intensity and quality of pain, physical and psychological functioning, and patients' global impression of change — 6 months after the initiation of the SCS implants.
Changes in sensory threshold with the novel PF-SCS modes as detected by QST — 6 months after the initiation of the SCS implants
Trial sites (1)
Facility
City
Region
Status
Toronto Western Hospital
Toronto
Ontario
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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